Viewing data from:

ACETAMINOPHEN

NDA

ACETAMINOPHEN | N204957 | B BRAUN MEDICAL INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Mallinckrodt IP et al v. B. Braun Medical Inc. 1:2017cv00660 2 patentsacetaminophen	D. Del.	2017-05-31	Terminated 2018-10-05	—
Mallinckrodt IP et al v. B. Braun Medical Inc. 1:2017cv00365 2 patentsacetaminophen	D. Del.	2017-04-03	Terminated 2018-10-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain23 active DMFs30 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCACETAMINOPHEN USP

DMF 53261984

ATABAY KIMYA SANAYI VE TICARET ASACETAMINOPHEN

DMF 62671986

SRI KRISHNA PHARMACEUTICALS LTDACETAMINOPHEN USP

DMF 158462002

ZHEJIANG KANGLE PHARMACEUTICAL CO LTDACETAMINOPHEN

DMF 162102002

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN USP

DMF 173432004

SRI KRISHNA PHARMACEUTICALS LTDACETAMINOPHEN GRANULES DC 90% (KRISOPAP 90F)

DMF 174412004

SRI KRISHNA PHARMACEUTICALS LTDACETAMINOPHEN GRANULES DC 90%

DMF 176062004

RHODIA ORGANIQUEACETAMINOPHEN USP

DMF 179132004

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC 90 3

DMF 191492006

GRANULES INDIA LTDACETAMINOPHEN USP

DMF 198042006

ANQUI LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC 90-3 SD

DMF 248872011

SHENZHOU JIHENG PHARMACEUTICAL CO LTDACETAMINOPHEN

DMF 262472012

HEBEI JIHENG GROUP PHARMACEUTICAL CO LTDACETAMINOPHEN DC 90%

DMF 262482012

ZHEJIANG KANGLE PHARMACEUTICAL CO LTDACETAMINOPHEN DC90

DMF 263422012

MEGHMANI LLPACETAMINOPHEN USP

DMF 302442016

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC90-7SD

DMF 316322017

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC90-10 SD

DMF 343372019

FARMSON BASIC DRUGS PRIVATE LTDACETAMINOPHEN USP

DMF 352402021

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC 90-9

DMF 366932022

APITORIA PHARMA PRIVATE LTDACETAMINOPHEN USP

DMF 368142022

IOL CHEMICALS AND PHARMACEUTICALS LTDACETAMINOPHEN USP (PARACETAMOL USP)

DMF 373362022

HEBEI JIHENG PHARMACEUTICAL CO LTDACETAMINOPHEN

DMF 377092022

MEGHMANI LLPACETAMINOPHEN USP

DMF 410592025

RHONE POULENC RORER PHARMACEUTICALS INCInactiveACETAMINOPHEN (BULK)

DMF 31421978

ELI LILLY AND COInactiveACETAMINOPHEN CAPSULES

DMF 35951979

PT RIASIMA ABADI INDUSTRI KIMIA FARMASI PERTAMAInactiveACETAMINOPHEN

DMF 46111982

SANOFI PHARMACEUTICALS INCInactiveACETAMINOPHEN

DMF 50481983

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveACETAMINOPHEN USP XX PWD & ACETAMINOPHEN W/10% STARCH

DMF 50611983

YAMAMOTO CHEMICAL INDUSTRIES CO LTDInactiveACETAMINOPHEN USP XX

DMF 55491984

MALLINCKRODT SPECIALTY CHEMICALS COInactiveACETAMINOPHEN

DMF 56831985

ILKIM ASInactiveACETAMINOPHEN USP

DMF 60271985

MIKART INCInactiveACETAMINOPHEN & CODEINE PHOSPHATE TABS. 650/60

DMF 60891985

MIKART INCInactiveACETAMINOPHEN AND HYDROCODONE BITARTRATE

DMF 62071986

HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTDInactiveACETAMINOPHEN USP

DMF 62451986

FARMSON PHARMACEUTICAL GUJARAT PRIVATE LTDInactiveACETAMINOPHEN

DMF 62761986

MATERIALS PROCESSING TECHNOLOGY INCInactiveACETAMINOPHEN 90%

DMF 63371986

HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTDInactiveACETAMINOPHEN D.C. PVP

DMF 65721986

HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTDInactiveACETAMINOPHEN D.C. 90 PVP

DMF 65731986

BASF CORPInactiveACETAMINOPHEN

DMF 74621988

REINO CHEMICAL INDUSTRIAL CORPInactiveACETAMINOPHEN

DMF 76761988

HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTDInactiveACETAMINOPHEN DC-PGS

DMF 77631988

DM GRAHAM LABORATORIES INCInactiveACETAMINOPHEN CONTROLLED-RELEASE BEADS 325 MG.

DMF 94761991

TRITON LABORATORIES PRIVATE LTDInactiveACETAMINOPHEN

DMF 99841992

INDUSTRIAS MONFEL SA DE CVInactiveACETAMINOPHEN

DMF 146381999

WUXI SHANHE GROUP NO 1 PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN (PARACETAMOL)

DMF 152262001

WENZHOU PHARMACEUTICAL FACTORYInactiveACETAMINOPHEN DC GRANULAR

DMF 163482003

HENGSHUI JIHENG PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN

DMF 170052003

DINESH PHARMACEUTICALS PRIVATE LTDInactiveACETAMINOPHEN USP

DMF 174792004

GRANULES INDIA LTDInactiveACETAMINOPHEN

DMF 177212004

ANQIU LUAN PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN DC 90 6

DMF 219612008

ANHUI BBCA LIKANG PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN

DMF 252132011

FARMSON PHARMACEUTICAL GUJARAT PRIVATE LTDInactiveACETAMINOPHEN USP

DMF 274672014

ZHEJIANG KANGLE PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN DC90 FINE

DMF 283022014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 22, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG/50ML (10MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 18, 2021

No patent or exclusivity listings for this strength.

#002 — 1GM/100ML (10MG/ML)

RLDAP2

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 18, 2021